A study to assess the efficacy and safety of LactoSpore in comparison with Placebo in Diabetes associated with abnormal lipid profile.

Not Applicable

Completed

• Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2017/01/007639
• Lead Sponsor: Sami Labs Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1 Patients with Dyslipidaemia and Type II Diabetes.

2 Age between 30 to 65 years.

3 Glucosylated haemoglobin level greater than equal to 6.6% and less than equal to 9.0% and total cholesterol greater than equal to 200mg/dl and less than equal to 239 mg/dl.

4 Have not consumed any probiotic for the last 2 months prior to recruitment.

5 Ability to comply with the study protocol.

Exclusion Criteria

1 Pregnant women,nursing mothers or subject who does not agree to assigned contraception in the study.

2 History of acute or chronic illness such as cancer or rheumatoid arthritis.

3 Using any medication such as steroids or antibiotics which might affect viability of gut microorganism at recruitment and during intervention phase.

4 Participation in a clinical study during the preceding 90 days.

5 Any contraindication to blood sampling.

6 Patients using yogurt in their daily meal.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 Myeloperoxidase <br/ ><br>2 Lipid Profile <br/ ><br>3 Diabetic Profile <br/ ><br>4 PAC-Quality of Life QuestionnaireTimepoint: 1 Myeloperoxidase(Day0 & Day90) <br/ ><br>2 Lipid Profile(Screening,Day45 & Day90) <br/ ><br>3 Diabetic Profile(Screening,Day45 & Day90)) <br/ ><br>4 PAC-Quality of Life Questionnaire(Day0,Day45 & Day90)

Secondary Outcome Measures

Name	Time	Method
1 Adverse events. <br/ ><br>2 Vital Signs. <br/ ><br>3 Laboratory parameters. <br/ ><br>Timepoint: 1 Adverse events(Day45 & Day90 <br/ ><br>2 Vital Signs(All visits). <br/ ><br>3 Laboratory parameters(Screening,Day45 & Day90).